Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 143
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- Ora-GUARD Dental Grind Guard (K150492): indications, design and recorded evidenceRegulatory decision evidence
- Oragene®Dx (K192920): indications, design and recorded evidenceRegulatory decision evidence
- Oral Lubricant (ONK) — FDA decisions, comparisons and evidenceFDA record research
- Oral-B Dry Mouth Oral Rinse (K201277): indications, design and recorded evidenceRegulatory decision evidence
- Orchid Safety Release ValveTM (K232094): indications, design and recorded evidenceRegulatory decision evidence
- Organic cotton tampon, Viscose tampon (K231341): indications, design and recorded evidenceRegulatory decision evidence
- Orthex External Fixation System (K223786): indications, design and recorded evidenceRegulatory decision evidence
- Orthex External Fixation System (K243798): indications, design and recorded evidenceRegulatory decision evidence
- OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268): indications, design and recorded evidenceRegulatory decision evidence
- OrthoPulse (K143120): indications, design and recorded evidenceRegulatory decision evidence
- OrthoPulse 2.0E (OPi2E-100) (K230905): indications, design and recorded evidenceRegulatory decision evidence
- Orthocem, Ortho Bite (K192682): indications, design and recorded evidenceRegulatory decision evidence
- Orthodontic Led Accessory (PLH) — FDA decisions, comparisons and evidenceFDA record research
- Orthopaedic Surgical Planning And Instrument Guides (PBF) — FDA decisions, comparisons and evidenceFDA record research
- Orthopedic Augmented Reality (SBF) — FDA decisions, comparisons and evidenceFDA record research
- Orthopedic Computer Controlled Surgical System (OJP) — FDA decisions, comparisons and evidenceFDA record research
- Orthopedic Stereotaxic Instrument (OLO) — FDA decisions, comparisons and evidenceFDA record research
- Orthosis, Cranial, Laser Scan (OAN) — FDA decisions, comparisons and evidenceFDA record research
- Orthosis, Limb, For Back Pain (PMV) — FDA decisions, comparisons and evidenceFDA record research
- Oscar Peripheral Multifunctional Catheter system (K214038): indications, design and recorded evidenceRegulatory decision evidence
- Osmolality Of Tears (OND) — FDA decisions, comparisons and evidenceFDA record research
- Osom Ultra Plus Flu A&B Test Kit (K192719): indications, design and recorded evidenceRegulatory decision evidence
- Ossiclear (Ossiclear System) (K254296): indications, design and recorded evidenceRegulatory decision evidence
- OsteoFab Patient Specific Cranial Device (K180064): indications, design and recorded evidenceRegulatory decision evidence
- OsteoMed ExtremiFix Mini & Small System Tray (K202105): indications, design and recorded evidenceRegulatory decision evidence
Page 143 of 228